Trial Outcomes & Findings for Managing Alcoholism in People Who Do Not Respond to Naltrexone (NCT NCT00115037)
NCT ID: NCT00115037
Last Updated: 2019-09-18
Results Overview
This is the number of patients who responded to phase 1 treatment based on the definition that subjects were randomly assigned to.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
302 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-09-18
Participant Flow
Study participants were recruited through advertisements in the local media, referrals from physicians, or self referrals.
All participants were offered medically monitored outpatient detox as needed.
Participant milestones
| Measure |
Phase1: Liberal
Relapse/non-responder defined as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase1: Stringent
Relapse/non-responder defined as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase2: Responder - Naltx (Usual Care)
Phase 2: Naltrexone and TAU for phase 1 responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase2: Responder - Naltx+Phone (TDM)
Phase 2: Naltrexone and telephone counseling for responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Telephone Counseling: Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
|
Phase2: Non-responder - Naltx, MM and CBI
Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
Phase2: Non-responder - Placebo, MM and CBI
Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR) placebo: placebo comparer for 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
|---|---|---|---|---|---|---|
|
Phase1
STARTED
|
152
|
150
|
0
|
0
|
0
|
0
|
|
Phase1
COMPLETED
|
127
|
123
|
0
|
0
|
0
|
0
|
|
Phase1
NOT COMPLETED
|
25
|
27
|
0
|
0
|
0
|
0
|
|
Phase2
STARTED
|
0
|
0
|
91
|
92
|
34
|
33
|
|
Phase2
COMPLETED
|
0
|
0
|
76
|
77
|
28
|
21
|
|
Phase2
NOT COMPLETED
|
0
|
0
|
15
|
15
|
6
|
12
|
Reasons for withdrawal
| Measure |
Phase1: Liberal
Relapse/non-responder defined as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase1: Stringent
Relapse/non-responder defined as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase2: Responder - Naltx (Usual Care)
Phase 2: Naltrexone and TAU for phase 1 responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase2: Responder - Naltx+Phone (TDM)
Phase 2: Naltrexone and telephone counseling for responders. Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Telephone Counseling: Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.
|
Phase2: Non-responder - Naltx, MM and CBI
Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
Phase2: Non-responder - Placebo, MM and CBI
Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR) placebo: placebo comparer for 16 weeks in phase 2. Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
|---|---|---|---|---|---|---|
|
Phase1
Lost to Follow-up
|
16
|
23
|
0
|
0
|
0
|
0
|
|
Phase1
Withdrawal by Subject
|
9
|
4
|
0
|
0
|
0
|
0
|
|
Phase2
Death
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Phase2
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
2
|
1
|
|
Phase2
Lost to Follow-up
|
0
|
0
|
12
|
14
|
4
|
10
|
Baseline Characteristics
Managing Alcoholism in People Who Do Not Respond to Naltrexone
Baseline characteristics by cohort
| Measure |
Phase1: Liberal
n=152 Participants
Definition B of heavy drinker: 5+ days of binge drinking
|
Phase1: Stringent
n=150 Participants
Definition A of heavy drinker: 2+ days of binge drinking
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
48.70 years
STANDARD_DEVIATION 10.40 • n=5 Participants
|
48.49 years
STANDARD_DEVIATION 10.36 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThis is the number of patients who responded to phase 1 treatment based on the definition that subjects were randomly assigned to.
Outcome measures
| Measure |
Phase 1 Liberal Response
n=127 Participants
From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase 1 Stringent Response
n=123 Participants
From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase 2 Nalt, MM and CBI for NR
Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
Phase 2 Placebo, MM and CBI for NR
Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR)
placebo: placebo comparer for 16 weeks in phase 2.
Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
|---|---|---|---|---|
|
Count of Responders and Non-responders in Phase 1
|
103 Participants
|
80 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 16 weeksPercentage of days with heavy drinking, where heavy drinking is 4 (5) or more drinks for females (males) in a 24 hour period.
Outcome measures
| Measure |
Phase 1 Liberal Response
n=83 Participants
From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 5 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase 1 Stringent Response
n=84 Participants
From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 2 or more heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder.
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
|
Phase 2 Nalt, MM and CBI for NR
n=30 Participants
Phase 2: naltrexone, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR).
Naltrexone: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
Phase 2 Placebo, MM and CBI for NR
n=27 Participants
Phase 2: placebo, Medication Management (MM) and Combined Behavioral Intervention (CBI) for non-responders (NR)
placebo: placebo comparer for 16 weeks in phase 2.
Medication Management (MM): Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Combined Behavioral Intervention (CBI): 45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Heavy Drinking Days
|
0 percentage days of heavy drinking
Interval 0.0 to 4.8
|
0 percentage days of heavy drinking
Interval 0.0 to 3.2
|
27.7 percentage days of heavy drinking
Interval 2.8 to 61.6
|
17.8 percentage days of heavy drinking
Interval 0.0 to 58.7
|
Adverse Events
Phase1: Liberal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase1: Stringent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase2: Responder - Naltx (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Phase2: Responder - Naltx+Phone (TDM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase2: Non-responder - Naltx, MM and CBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase2: Non-responder - Placebo, MM and CBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place